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DRUG:

leuprolide acetate for depot suspension

i
Other names: TAP-144-SR, TAP-144SR, TAP-144, TAP-144-SR (6M), DWJ 108J, PT105
Company:
Generic mfg.
Drug class:
GnRH agonist
5d
Study on the role of probiotics in alleviating leuprolide-induced perimenopausal syndrome in assisted reproductive therapy (ChiCTR2400089614)
P=N/A, N=150, Not yet recruiting, Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine; Reproductive Hospital Affiliated to Jiangxi University of Trad
New trial
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leuprolide acetate for depot suspension
25d
New P3 trial • Metastases
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abiraterone acetate • bicalutamide • Orgovyx (relugolix) • leuprolide acetate for depot suspension • Yonsa (abiraterone acetate)
1m
Menopausal Sleep Fragmentation and Body Fat Gain (clinicaltrials.gov)
P4, N=41, Completed, Brigham and Women's Hospital | N=125 --> 41
Enrollment change
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LEP (Leptin)
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leuprolide acetate for depot suspension
2ms
Enrollment closed
|
DRD (DNA Repair Deficiency)
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DDR • DRD
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Zejula (niraparib) • abiraterone acetate • leuprolide acetate for depot suspension
2ms
Her2-positive breast cancer in a young patient with Li-Fraumeni syndrome: A comprehensive case study. (PubMed, Int J Surg Case Rep)
Managing Li-Fraumeni syndrome (LFS) and its associated cancers, particularly in young patients, necessitates a comprehensive and multidisciplinary approach. Early genetic testing for TP53 mutations is crucial in identifying LFS, enabling personalized treatment plans and proactive surveillance strategies.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PGR (Progesterone receptor)
|
HER-2 positive • TP53 mutation • ER-L • PGR negative
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Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • leuprolide acetate for depot suspension
2ms
PROSTSIZE: Prostatic Size Reduction Following of Leuprorelin Acetate (clinicaltrials.gov)
P=N/A, N=40, Recruiting, Consorci Sanitari de Terrassa | Trial primary completion date: Jul 2024 --> Dec 2024
Trial primary completion date
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leuprolide acetate for depot suspension
3ms
PRESTO: A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (clinicaltrials.gov)
P3, N=504, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date
|
abiraterone acetate • prednisone • bicalutamide • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
4ms
New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
4ms
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
P2, N=32, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Jul 2028 | Trial primary completion date: Jan 2027 --> Jul 2027
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
|
docetaxel • Tevimbra (tislelizumab-jsgr) • Xtandi (enzalutamide capsule) • abiraterone acetate • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
4ms
Combination therapy • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
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OncoPanel™ Assay
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Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
4ms
Consenso de expertos basado en la evidencia: perfilamiento y manejo del carcinoma epitelial de ovario de alto grado avanzado. (PubMed, Rev Colomb Obstet Ginecol)
Se sugiere utilizar bevacizumab u olaparib más bevacizumab en pacientes con CEO estadios III/IV BRCA1/2 negativo o desconocido (HRD positivo) que recibieron quimioterapia basada en platino más bevacizumab y obtuvieron RC/RP...Para pacientes con CEO de alto grado avanzado o metastásico en recaída platino-sensibles se sugiere: • Quimioterapia combinada basada en platino: carboplatino/doxorrubicina liposomal o carboplatino/paclitaxel o carboplatino/ nab-paclitaxel o carboplatino/docetaxel o carboplatino/gemcitabina, por seis ciclos. Si no se tolera la terapia combinada, dar carboplatino o cisplatino solo. • Quimioterapia combinada: carboplatino/gemcitabina o carboplatino/paclitaxel o carboplatino/doxorubicina liposomal, más bevacizumab, seguida de bevacizumab como mantenimiento (hasta progresión o toxicidad)...El paclitaxel semanal o la doxorrubicina liposomal pegilada o el topotecan pueden ser administrados con o sin bevacizumab. • Existen otros agentes que se consideran potencialmente act ivos (capecitabina, ciclofosfamida, ifosfamida, irinotecán, oxaliplatino, pemetrexed, vinorelbina, ciclofosfamida), que se podrían recomendar para líneas posteriores. • Las pacientes con receptores hormonales positivos que no toleran o no tienen respuesta a los regímenes citotóxicos pueden recibir terapia hormonal con tamoxifeno u otros agentes, incluidos los inhibidores de la aromatasa (anastrozol y letrozol) o acetato de leuprolide o acetato de megestrol...El niraparib podría ser útil en pacientes BRCA 1/2 +/-/desconocido, al igual que el rucaparib, sin embargo, este último no tiene aún aprobación del ente regulador en Colombia. Conclusiones: se espera que las recomendaciones emitidas en este consenso contribuyan a mejorar la atención clínica, el impacto oncológico y la calidad de vida de estas mujeres.
Clinical guideline • Journal
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • PARP1 (Poly(ADP-Ribose) Polymerase 1)
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Avastin (bevacizumab) • Lynparza (olaparib) • cisplatin • carboplatin • gemcitabine • tamoxifen • Zejula (niraparib) • Rubraca (rucaparib) • albumin-bound paclitaxel • pemetrexed • topotecan • megestrol • leuprolide acetate for depot suspension
4ms
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • anastrozole • exemestane • AiRuiKang (dalpiciclib) • goserelin acetate • leuprolide acetate for depot suspension
4ms
Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer (clinicaltrials.gov)
P3, N=154, Recruiting, Dongkook Pharmaceutical Co., Ltd.
New P3 trial
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leuprolide acetate for depot suspension
5ms
A case of breast cancer metastasis to the tibia that was difficult to diagnose (JBCS 2024)
A partial mastectomy and sentinel lymph node biopsy were performed, and the diagnosis was T2 (23 mm), N0 (sn: 0/2), M0: Stage IIA, ER positive, PgR negative, HER2 score 0, Ki-67 index: 25%, Curebest95: H. Leuprorelin was used intermittently for uterine fibroids, but menopause had not occurred, and postoperative drug therapy was continued with tamoxifen (combined with UFT2 for 2 years after surgery) to avoid hair loss...As menopausal status was confirmed, palbociclib was administered in combination with letrozole and the patient is currently under observation. Conclusion During hormone therapy for breast cancer, knee pain is often experienced as an adverse event due to the decrease in estrogen due to aging and joint deformation. In cases such as this case where conservative treatment does not improve the condition and the condition continues for a long time, a detailed examination should be considered with the exclusion of bone metastasis in mind, although this is rare
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • GATA3 (GATA binding protein 3)
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Curebest™ 95GC Breast
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Ibrance (palbociclib) • tamoxifen • letrozole • leuprolide acetate for depot suspension
5ms
Neoadjuvant Ipilimumab in Prostate Cancer (clinicaltrials.gov)
P2, N=19, Completed, M.D. Anderson Cancer Center | Phase classification: P2a --> P2
Phase classification
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
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Yervoy (ipilimumab) • leuprolide acetate for depot suspension
5ms
Enrollment open • Metastases
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Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
5ms
SNARE: A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (clinicaltrials.gov)
P2, N=30, Recruiting, VA Office of Research and Development | Not yet recruiting --> Recruiting | Trial completion date: Nov 2027 --> Aug 2027 | Trial primary completion date: Nov 2026 --> May 2027
Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
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PTEN (Phosphatase and tensin homolog)
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abiraterone acetate • Truqap (capivasertib) • leuprolide acetate for depot suspension
5ms
Detect V / CHEVENDO (Chemo vs. Endo) (clinicaltrials.gov)
P3, N=271, Active, not recruiting, Prof. Wolfgang Janni | Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Jan 2025 | Trial primary completion date: Sep 2024 --> Jan 2025
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • capecitabine • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • anastrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
5ms
REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov)
P4, N=93, Active, not recruiting, Emory University | Recruiting --> Active, not recruiting | Trial completion date: Apr 2025 --> Jan 2026 | Trial primary completion date: Apr 2024 --> Jan 2025
Enrollment closed • Trial completion date • Trial primary completion date
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Orgovyx (relugolix) • leuprolide acetate for depot suspension
6ms
Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy (clinicaltrials.gov)
P2, N=64, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
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sunitinib • leuprolide acetate for depot suspension
6ms
Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, University of Colorado, Denver | Trial completion date: Apr 2024 --> Apr 2025
Trial completion date
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Xtandi (enzalutamide capsule) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
7ms
New P3 trial
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Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
7ms
REPLACE-CV: Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate (clinicaltrials.gov)
P3, N=2250, Active, not recruiting, Sumitomo Pharma Switzerland GmbH | Trial completion date: Feb 2027 --> Dec 2024 | Trial primary completion date: Feb 2027 --> Dec 2024
Trial completion date • Trial primary completion date • Adverse events
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Orgovyx (relugolix) • leuprolide acetate for depot suspension
7ms
Personalized neoadjuvant strategy in ER positive and HER2 negative breast cancer to increase BCS rate (PLATO): A prospective, multicenter, phase II clinical trial. (ASCO 2024)
Based on the 70-gene assay results from core needle biopsies, high-genomic-risk patients received NCT (anthracycline + cyclophosphamide for 4 cycles, followed by 4 cycles of docetaxel), while low-risk patients underwent 16 weeks of NET with letrozole (±leuprolide for premenopausal women). For ER positive, HER2 negative breast cancer patients initially ineligible for BCS, the use of pre-treatment multi-gene assays to guide selective NCT or NET could substantially increase BCS rates and reduce unnecessary chemotherapy.
P2 data • Clinical
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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MammaPrint
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docetaxel • cyclophosphamide • letrozole • leuprolide acetate for depot suspension
7ms
Combination therapy • Enrollment closed • Metastases
|
PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
|
PD-L1 expression • MSI-H/dMMR
|
OncoPanel™ Assay
|
Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
7ms
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov)
P=N/A, N=1, Completed, Pfizer | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Apr 2024
Trial completion date • Trial primary completion date • HEOR • Real-world evidence • Real-world • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • leuprolide acetate for depot suspension
7ms
ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov)
P3, N=3100, Suspended, Novartis Pharmaceuticals | Recruiting --> Suspended
Trial suspension
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive
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Kisqali (ribociclib) • letrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
7ms
New P2 trial • Metastases
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
7ms
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect (clinicaltrials.gov)
P=N/A, N=94, Recruiting, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting --> Recruiting
Enrollment open
|
leuprolide acetate for depot suspension
7ms
Trial completion • HEOR • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Herceptin (trastuzumab) • paclitaxel • tamoxifen • Perjeta (pertuzumab) • cyclophosphamide • letrozole • epirubicin • anastrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
7ms
Micro RNAs to Predict Response to Androgen Deprivation Therapy (clinicaltrials.gov)
P=N/A, N=42, Active, not recruiting, Medical College of Wisconsin | N=60 --> 42
Enrollment change
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docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
8ms
New P2 trial
|
leuprolide acetate for depot suspension • Airui'en (rezvilutamide)
8ms
Immunoprofiles and Oncologic Outcomes of 15 Patients with Androgen Receptor-Positive Salivary Duct Carcinoma. (PubMed, Cancers (Basel))
Despite only including AR+ SDC of the parotid, immunoprofiles, such as expression of HER-2, were highly variable, highlighting the potential to tailor systemic regimens based on individual histologic profiles in the future. Studies with larger patient numbers using tumor-specific molecular profiling and tumor heterogeneity analyses are justified to better understand the biology of these tumors. Molecularly informed treatment approaches, including the potential use of AR- and HER-2/Neu-directed therapies upfront in the definitive setting, may hold future promise to further improve outcomes for these patients.
Journal
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AR (Androgen receptor)
|
HER-2 expression • AR positive
|
Herceptin (trastuzumab) • bicalutamide • leuprolide acetate for depot suspension
8ms
A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer (clinicaltrials.gov)
P2, N=0, Withdrawn, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=30 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal
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abiraterone acetate • Welireg (belzutifan) • leuprolide acetate for depot suspension
8ms
Transcriptome profiling reveals superovulation with the gonadotropin-releasing hormone agonist trigger impaired embryo implantation in mice. (PubMed, Front Endocrinol (Lausanne))
Mice in the superovulation (PG) group were administered 7.5 IU of PMSG, followed by the injection of 3.5 μg of GnRHa (Leuprorelin) 48 h later, while mice in the control group (CTR) mated naturally...The transcriptome analysis showed that superphysiological estrogen led to a response of the uterus to a high estrogen signal, resulting in abnormal endometrium and extracellular matrix remodeling and up-regulation of ion transport and inflammation-related genes. Our findings suggest that a combination of PMSG and GnRHa trigger impaired embryo implantation in mice, as the excessive uterine response to superphysiological estrogen levels can lead to the change of gene expression related to endometrial remodeling, abnormal expression of uterine ion transport genes and excessive immune-related genes.
Preclinical • Journal
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LIF (LIF Interleukin 6 Family Cytokine)
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leuprolide acetate for depot suspension
8ms
Enrollment change • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive
|
trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • Airui'en (rezvilutamide) • SHR-A1921
9ms
Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis (clinicaltrials.gov)
P1, N=30, Active, not recruiting, Colorado Center for Reproductive Medicine | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
leuprolide acetate for depot suspension
9ms
ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov)
P3, N=3100, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive
|
Kisqali (ribociclib) • letrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
9ms
ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov)
P3, N=3100, Not yet recruiting, Novartis Pharmaceuticals | Trial primary completion date: Jul 2028 --> Sep 2029
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive
|
Kisqali (ribociclib) • letrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
9ms
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty (clinicaltrials.gov)
P4, N=80, Recruiting, Takeda | Trial completion date: Apr 2024 --> May 2025 | Trial primary completion date: Jan 2024 --> May 2025
Trial completion date • Trial primary completion date
|
leuprolide acetate for depot suspension
9ms
SAVE: Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (clinicaltrials.gov)
P2, N=202, Recruiting, Cancer Research Antwerp | Trial completion date: Sep 2022 --> Dec 2025 | Trial primary completion date: Dec 2021 --> Aug 2025
Trial completion date • Trial primary completion date • Combination therapy
|
Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
9ms
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
P2, N=31, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Phase classification: P2a --> P2 | Trial completion date: May 2026 --> Jan 2027 | Trial primary completion date: May 2025 --> Jan 2027
Phase classification • Trial completion date • Trial primary completion date • Metastases
|
docetaxel • Tevimbra (tislelizumab-jsgr) • Xtandi (enzalutamide capsule) • abiraterone acetate • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension